510(k) · Cleared

Cleared

BD Pen Needle

K100005510(k) SpecialCleared Apr 15, 2010101-day reviewClass II21 CFR 880.5570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Becton, Dickinson and Co. · FMI Needle, Hypodermic, Single Lumen

Cleared on Apr 15, 2010 as substantially equivalent to K051899 (Becton, Dickinson & CO, 2005) after a 101-day review. Its family tree reaches back 1 generation to 2005. 59 later devices descend from it.

Decided: Apr 15, 2010
Review: 101 days
Class: Class II
Product code: FMI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K051899 (2005). 59 later devices descend from it, 10 citing it directly.

By dateBy generation

Root · 1 generation backK051899 BD Pen NeedleBecton, Dickinson & CO · 2005
This deviceK100005 BD Pen NeedleBecton, Dickinson and Co. · 2010
Descendant · cites it directly · 21 of its ownK112332 Fine Ject Insulin Pen NeedleTwobiens Co., Ltd. · 2012
Descendant · cites it directly · 20 of its ownK123300 BD Pen NeedleBecton, Dickinson & CO · 2013
Descendant · 2 generations on · 20 of its ownK120690 Insulin Pen NeedleTiger Medical Products, Ltd. · 2012
Descendant · 3 generations on · 18 of its ownK133059 Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd. · 2014
Descendant · cites it directly · 11 of its ownK131358 BD Pen NeedleBecton, Dickinson & CO · 2013

Showing 5 of 59 descendants. See all descendants

Descendants cleared per year

2011high 7 (2014) · low 1 (2019)2026

Most influential descendants

Showing 5 of 59 · See all

K112332Fine Ject Insulin Pen NeedleTwobiens Co., Ltd. · 2012 · cites it directly21descendants
K123300BD Pen NeedleBecton, Dickinson & CO · 2013 · cites it directly20descendants
K120690Insulin Pen NeedleTiger Medical Products, Ltd. · 2012 · 2 generations on20descendants
K133059Insulin Pen NeedleWenzhou Beipu Science & Technology Co., Ltd. · 2014 · 3 generations on18descendants
K131358BD Pen NeedleBecton, Dickinson & CO · 2013 · cites it directly11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K051899	BD Pen Needle	Becton, Dickinson & CO	2005	—
0 (this device)	K100005	BD Pen Needle	Becton, Dickinson and Co.	2010	—
+1	K112332	Fine Ject Insulin Pen Needle	Twobiens Co., Ltd.	2012	—
+1	K123300	BD Pen Needle	Becton, Dickinson & CO	2013	—
+2	K120690	Insulin Pen Needle	Tiger Medical Products, Ltd.	2012	—
+3	K133059	Insulin Pen Needle	Wenzhou Beipu Science & Technology Co., Ltd.	2014	—
+1	K131358	BD Pen Needle	Becton, Dickinson & CO	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2012	4	0
2013	3	0
2014	7	0
2015	2	0
2016	5	0
2017	3	0
2018	3	0
2019	1	0
2020	6	0
2021	7	0
2022	5	0
2023	5	0
2024	1	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K100005, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FMI device

#1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K051899	BD Pen Needle	Becton, Dickinson & CO	2005	—
*	—	BD Pen Needle 31G x 5mm Named without a submission number			—
*	—	BD Pen Needle 31G x 8mm Named without a submission number			—

Also cleared against K051899: 13 other devices →

What descends from it? (59)

See all 59

10 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K112332	Fine Ject Insulin Pen Needle	Twobiens Co., Ltd.	2012	21
K123300	BD Pen Needle	Becton, Dickinson & CO	2013	20
K131358	BD Pen Needle	Becton, Dickinson & CO	2013	11
K143437	Droplet Pen Needles	Htl-Strefa S.A	2015	4
K113186	Sterile Insulin Pen Needle	Shina Corp.	2012	4
K133100	Carefine Pen Needle	Facet Technologies	2014	3
K131125	Clickfine Pen Needle	Ypsomed AG	2013	1
K121632	Comfort EZ	Simple Diagnostics, Inc.	2012	1
K112789	Easy Touch	Mhc Medical Products, LLC	2011	0
K110105	BD Pen Needle	Becton, Dickinson and Company (BD)	2011	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K112332 (Twobiens Co., Ltd., 2012) has gone furthest, with 21 descendants of its own.
13 other devices also cite its predicate K051899.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · FMI

11in 2025

2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007high 263 (2020) · low 71 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMI

1in 2024

2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	15	71	2	208
2008	10	85	4	177
2009	7	177	3	263
2010	15	119	79	249
2011	12	113	5	240
2012	17	107	1	215
2013	11	87	1	255
2014	14	155	3	287
2015	10	89	1	567
2016	20	217	0	941
2017	9	253	16	1,547
2018	20	176	0	2,398
2019	12	186	5	4,896
2020	11	263	3	4,245
2021	18	143	7	4,532
2022	23	189	0	4,885
2023	18	112	2	4,986
2024	3	90	1	4,053
2025	11	141	0	2,424
2026	12	119	1 (1)	—

What is it indicated for?

BD Pen Needle is intended for use with pen injector device for subcutaneous injection of drugs, including insulin and exenatide.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100005 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100005: BD Pen Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100005

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026